Dyslipidemias, Hypercholesterolemia, Familial Hypercholesterolemia, ASCVD, High Cholesterol
Conditions
Keywords
obicetrapib, statin, LDL-C, cholesterol, atherosclerosis
Brief summary
The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy.
Detailed description
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy. The screening period for this study will take up to 14 days. Afterwards patients will be randomized 1:1:1:1 to Obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination, obicetrapib 10 mg, ezetimibe 10 mg or placebo for a 84 day treatment period. After the treatment period, patients will have an end of study follow-up visit.
Interventions
COMBINATION_PRODUCTCombination Therapy
tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination
DRUGMonotherapy obicetrapib
tablet; 10mg obicetrapib
DRUGMonotherapy ezetimibe
capsule; 10mg ezetimibe
OTHERCombination Therapy placebo
tablet; no active ingredient
OTHERObicetrapib Placebo
tablet; no active ingredient
OTHEREzetimibe Placebo
capsule; no active ingredient
Sponsors
NewAmsterdam Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
placebo tablets made to resemble active; placebo capsule made to resemble active
Intervention model description
Placebo-controlled, double blind, randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have underlying HeFH and/or a history of ASCVD or multiple ASCVD risk factors * On maximally tolerated lipid-modifying therapy as an adjunct to a diet and lifestyle modifications * LDL-C ≥ 70 mg/dL * Triglycerides \< 500 * Estimated glomerular filtration rate ≥ 15 mL/min/1.73 m2
Exclusion criteria
* History of New York Heart Association (NYHA) class III or IV heart failure of left ventricular ejection fraction \<30% * Hospitalized for heart failure within the last 5 years * Myocardial infarction, stroke, non-elective coronary revascularization or hospitalization for unstable angina or chest pain in the last 3 months * Uncontrolled severe hypertension * Diagnosis of homozygous FH * Liver disease * HbA1c ≥ 10.0% or fasting glucose ≥ 270 mg/dL * Thyroid-stimulating hormone \>1.5 x upper limit of normal (ULN) * History of malignancy * Creatinine kinase (CK) \>3 X ULN * Alcohol abuse * Treatment with investigational product * Treatment with gemfibrozil or ezetimibe * Previous participation in a trial evaluating obicetrapib * Known allergy to study drugs, placebo or excipients in study drugs of placebo * Other condition that would interfere with the conduct of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C | 84 Days | LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC). |
| Effect of Fixed Dose Combination (FDC) Compared to Ezetimibe Monotherapy on LDL-C | 84 Days | LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg group. LDL-C level was measured by preparative ultracentrifugation (PUC). |
| Effect of Fixed Dose Combination (FDC) Compared to Obicetrapib Monotherapy on LDL-C | 84 Days | LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10 mg group. LDL-C level was measured by preparative ultracentrifugation (PUC). |
| Effect of Obicetrapib Monotherapy Compared to Placebo on LDL-C | 84 Days | LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Non-HDL-C | 84 Days | LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg group. |
| Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Apolipoprotein B (ApoB) | 84 Days | LS mean percent change in apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg group. |
| Effect of Fixed Dose Combination (FDC) Compared to Placebo on Non-HDL-C | 84 Days | LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group. |
| Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Apolipoprotein B (ApoB) | 84 Days | LS mean percent change in Apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10 mg group. |
| Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Non-HDL-C | 84 Days | LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10mg group. |
| Effect of Fixed Dose Combination (FDC) Compared to Placebo on Apolipoprotein B (ApoB) | 84 Days | LS mean percent change in apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group. |
| Effect of Obicetrapib Monotherapy Compared to Placebo on Non-HDL-C | 84 Days | LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib monotherapy 10 mg group compared to the placebo group. |
| Effect of Obicetrapib Monotherapy Compared to Placebo on Apolipoprotein B (ApoB) | 84 Days | LS mean percent change in apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib monotherapy 10 mg group compared to the placebo group. |
Countries
United States
Participant flow
Recruitment details
716 participants were screened: out of 716, 407 participants were randomized (1:1:1:1) (FDC therapy: Obicetrapib monotherapy: Ezetimibe monotherapy: placebo)
Participants by arm
| Arm | Count |
|---|---|
| Fixed Dose Combination once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Fixed Dose Combination: tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient | 102 |
| Monotherapy Obicetrapib once-daily obicetrapib 10 mg, placebo tablet, placebo capsule
Monotherapy obicetrapib: tablet; 10mg obicetrapib
Combination Therapy placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient | 102 |
| Monotherapy Ezetimibe once-daily ezetimibe 10 mg capsule, 2 placebo tablets
Monotherapy ezetimibe: capsule; 10mg ezetimibe
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient | 101 |
| Placebo once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient | 102 |
| Total | 407 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 1 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 | 1 | 2 |
Baseline characteristics
| Characteristic | Fixed Dose Combination | Monotherapy Obicetrapib | Monotherapy Ezetimibe | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 67.3 years STANDARD_DEVIATION 9.43 | 66.7 years STANDARD_DEVIATION 9.64 | 67.6 years STANDARD_DEVIATION 8.71 | 66.1 years STANDARD_DEVIATION 9.47 | 66.9 years STANDARD_DEVIATION 9.3 |
| Baseline Low-Density Lipoprotein Cholesterol (LDL-C) | 96.5 mg/dL STANDARD_DEVIATION 28.8 | 100.0 mg/dL STANDARD_DEVIATION 35.34 | 98.2 mg/dL STANDARD_DEVIATION 31.09 | 91.0 mg/dL STANDARD_DEVIATION 25.81 | 96.4 mg/dL STANDARD_DEVIATION 30.26 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 1 Participants | 2 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants | 100 Participants | 100 Participants | 100 Participants | 398 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 15 Participants | 13 Participants | 17 Participants | 59 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 86 Participants | 85 Participants | 82 Participants | 84 Participants | 337 Participants |
| Sex: Female, Male Female | 48 Participants | 33 Participants | 45 Participants | 51 Participants | 177 Participants |
| Sex: Female, Male Male | 54 Participants | 69 Participants | 56 Participants | 51 Participants | 230 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 102 | 1 / 102 | 1 / 101 | 0 / 102 |
| other Total, other adverse events | 30 / 102 | 62 / 102 | 35 / 101 | 17 / 102 |
| serious Total, serious adverse events | 3 / 102 | 6 / 102 | 7 / 101 | 4 / 102 |
Outcome results
Primary
Effect of Fixed Dose Combination (FDC) Compared to Ezetimibe Monotherapy on LDL-C
LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Time frame: 84 Days
Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fixed Dose Combination | Effect of Fixed Dose Combination (FDC) Compared to Ezetimibe Monotherapy on LDL-C | -45.58 percent change from baseline | Standard Error 3.465 |
| Placebo | Effect of Fixed Dose Combination (FDC) Compared to Ezetimibe Monotherapy on LDL-C | -17.63 percent change from baseline | Standard Error 3.497 |
p-value: <0.000195% CI: [-37.53, -18.35]ANCOVA
Primary
Effect of Fixed Dose Combination (FDC) Compared to Obicetrapib Monotherapy on LDL-C
LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10 mg group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Time frame: 84 Days
Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fixed Dose Combination | Effect of Fixed Dose Combination (FDC) Compared to Obicetrapib Monotherapy on LDL-C | -45.58 percent change from baseline | Standard Error 3.465 |
| Placebo | Effect of Fixed Dose Combination (FDC) Compared to Obicetrapib Monotherapy on LDL-C | -28.82 percent change from baseline | Standard Error 3.484 |
p-value: 0.000795% CI: [-26.4, -7.12]ANCOVA
Primary
Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C
LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Time frame: 84 Days
Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fixed Dose Combination | Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C | -45.58 percent change from baseline | Standard Error 3.465 |
| Placebo | Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C | 3.03 percent change from baseline | Standard Error 3.564 |
p-value: <0.000195% CI: [-58.33, -38.89]ANCOVA
Primary
Effect of Obicetrapib Monotherapy Compared to Placebo on LDL-C
LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Time frame: 84 Days
Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fixed Dose Combination | Effect of Obicetrapib Monotherapy Compared to Placebo on LDL-C | -28.82 percent change from baseline | Standard Error 3.484 |
| Placebo | Effect of Obicetrapib Monotherapy Compared to Placebo on LDL-C | 3.03 percent change from baseline | Standard Error 3.564 |
p-value: <0.000195% CI: [-41.64, -22.07]ANCOVA
Secondary
Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Apolipoprotein B (ApoB)
LS mean percent change in apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg group.
Time frame: 84 Days
Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fixed Dose Combination | Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Apolipoprotein B (ApoB) | -26.91 percent change from baseline | Standard Error 2.425 |
| Placebo | Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Apolipoprotein B (ApoB) | -12.71 percent change from baseline | Standard Error 2.495 |
p-value: <0.000195% CI: [-21.06, -7.36]ANCOVA
Secondary
Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Non-HDL-C
LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg group.
Time frame: 84 Days
Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fixed Dose Combination | Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Non-HDL-C | -42.42 percent change from baseline | Standard Error 2.977 |
| Placebo | Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Non-HDL-C | -16.98 percent change from baseline | Standard Error 3.006 |
p-value: <0.000195% CI: [-33.67, -17.22]ANCOVA
Secondary
Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Apolipoprotein B (ApoB)
LS mean percent change in Apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10 mg group.
Time frame: 84 Days
Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fixed Dose Combination | Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Apolipoprotein B (ApoB) | -26.91 percent change from baseline | Standard Error 2.425 |
| Placebo | Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Apolipoprotein B (ApoB) | -17.50 percent change from baseline | Standard Error 2.482 |
p-value: 0.00795% CI: [-16.26, -2.57]ANCOVA
Secondary
Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Non-HDL-C
LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10mg group.
Time frame: 84 Days
Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fixed Dose Combination | Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Non-HDL-C | -42.42 percent change from baseline | Standard Error 2.977 |
| Placebo | Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Non-HDL-C | -27.19 percent change from baseline | Standard Error 3.01 |
p-value: 0.000395% CI: [-23.53, -6.93]ANCOVA
Secondary
Effect of Fixed Dose Combination (FDC) Compared to Placebo on Apolipoprotein B (ApoB)
LS mean percent change in apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group.
Time frame: 84 Days
Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fixed Dose Combination | Effect of Fixed Dose Combination (FDC) Compared to Placebo on Apolipoprotein B (ApoB) | -26.91 percent change from baseline | Standard Error 2.425 |
| Placebo | Effect of Fixed Dose Combination (FDC) Compared to Placebo on Apolipoprotein B (ApoB) | 2.28 percent change from baseline | Standard Error 2.466 |
p-value: <0.000195% CI: [-35.99, -22.4]ANCOVA
Secondary
Effect of Fixed Dose Combination (FDC) Compared to Placebo on Non-HDL-C
LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group.
Time frame: 84 Days
Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fixed Dose Combination | Effect of Fixed Dose Combination (FDC) Compared to Placebo on Non-HDL-C | -42.42 percent change from baseline | Standard Error 2.977 |
| Placebo | Effect of Fixed Dose Combination (FDC) Compared to Placebo on Non-HDL-C | 2.71 percent change from baseline | Standard Error 3.017 |
p-value: <0.000195% CI: [-53.43, -36.84]ANCOVA
Secondary
Effect of Obicetrapib Monotherapy Compared to Placebo on Apolipoprotein B (ApoB)
LS mean percent change in apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib monotherapy 10 mg group compared to the placebo group.
Time frame: 84 Days
Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fixed Dose Combination | Effect of Obicetrapib Monotherapy Compared to Placebo on Apolipoprotein B (ApoB) | -17.50 percent change from baseline | Standard Error 2.482 |
| Placebo | Effect of Obicetrapib Monotherapy Compared to Placebo on Apolipoprotein B (ApoB) | 2.28 percent change from baseline | Standard Error 2.466 |
p-value: <0.000195% CI: [-26.73, -12.82]ANCOVA
Secondary
Effect of Obicetrapib Monotherapy Compared to Placebo on Non-HDL-C
LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib monotherapy 10 mg group compared to the placebo group.
Time frame: 84 Days
Population: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fixed Dose Combination | Effect of Obicetrapib Monotherapy Compared to Placebo on Non-HDL-C | -27.19 percent change from baseline | Standard Error 3.01 |
| Placebo | Effect of Obicetrapib Monotherapy Compared to Placebo on Non-HDL-C | 2.71 percent change from baseline | Standard Error 3.017 |
p-value: <0.000195% CI: [-38.28, -21.53]ANCOVA